Ultrasonic transducer assembly

ABSTRACT

An ultrasound transducer assembly includes an acoustic focusing lens and a therapy transducer mounted to a holder member so that the lens is movable relative to the transducer. The lens and the transducer are mounted to the holder member so that the lens is spaced a predetermined distance from the transducer element. A liquid layer having a thickness of the predetermined distance is provided between the lens and the transducer element. A solid backing member is disposed on a side of the transducer element opposite the lens. The backing member is spaced by an additional liquid layer of a predetermined thickness from the transducer element. The focusing depth of the lens-transducer assembly is controllable by transducer operating frequency.

FIELD OF THE INVENTION

This invention relates to an ultrasonic transducer assembly. Theinvention is particularly useful in medical diagnostic and therapeuticapplications.

BACKGROUND OF THE INVENTION

Ultrasound is widely used in modern medicine for diagnostics andminimally invasive treatment in such fields as obstetrics, cardiology,endocrinology, gastroenterology, neurology, ophthalmology, urology,osteoporosis, and clinical diagnostics. Ultrasound diagnostics useslow-power ultrasonic scanners for investigation and visualization ofinner organs, tissue layers and structures, for determination of bloodflow direction and velocity, for measurement of density and otherparameters of tissues, and for detection of cancer and other tumors. Indiagnostics, acoustic lenses have been traditionally used in pulse modeto manipulate the wave front propagation delays. In therapeuticapplications, continuous ultrasound waves with an average acousticintensity of up to several watts per centimeter square at the transducersurface are typically used to focus ultrasound. The focused ultrasonicwaves produce highly localized and intense acoustic fields, up toseveral hundreds of watts in power density, and enable controlled,deep-reaching and localized treatment of malignant tissues, with fewsecondary effects for surrounding health tissues. It is beneficial tocontrol ultrasonic energy deposition for quickly overheating targetfocal tissue while minimizing the impact on surrounding non-targetedtissues. The mastery of focusing determines the success of therapy andrequires an understanding of the vibration condition of the radiatingsurface and thermal and mechanical constraints. Because acousticfocusing is an interference phenomenon, the phase of individualultrasound rays becomes a controlling factor in a continuous therapymode. In a diagnostic imaging mode, focusing limits the beam width andconstrains the acoustic energy content of the beam to a smaller crosssectional area, hence improving imaging sensitivity. In this mode, thebeam is typically focused using a fixed lens that just bends acousticrays and preserves the pressure-time waveform of incoming signals.Imaging lenses are used in pulsed mode where their function reliesprimarily on determining and manipulating the wave front propagationdelays. For therapeutics, the mode of operation is typically continuouswave, in which case the phase becomes an important lens design factor asopposed to wave front propagation delay. Traditional convex or concavelenses (Folds, Focusing properties of solid ultrasound cylindricallenses, 53, 3, pp 826-834, 1973) that converge light rays towards thelens principal axis offer a simple method to focus low power acousticenergy in both therapy and imaging. However, high acoustic absorption inthicker regions of the lenses and excessive heat build up result in apoor lens longevity and large focusing aberration when attempts are madeto focus high power acoustic energy in a continuous regime. Hence, thinfocusing lenses with discrete phase shifts are both permissible andbeneficiary in therapy, greatly reducing overall lens depth profile andallowing different designs, including zone plate Fresnel (Hadimioglu etal, 1993), multilevel (Chan et al, Finite element analysis of multilevelacoustic Fresnel lenses, Vol 43, 4, 1996), field conjugate (Lalonde andHunt, Variable frequency field conjugate lenses for ultrasoundhyperthermia, 42, 5, 825-831, 1995) and other designs (Rosenberg, Highintensity ultrasound, Moscow, pp 69-91, 1949; Tarnoczy, Sound focusinglenses and waveguides, Ultrasonics, 115-127, 1965).

Discrete phase acoustic focusing lenses in combination with flattransducers or arrays offer an elegant and cost effective solution forhyperthermia treatment of cancer and tumors, where the tissue is heatedusing ultrasound to temperatures of 43-45° C. for several minutes. It iswell known that tumor cells become much more susceptible to radiotherapyand chemotherapy under elevated temperature. In physiotherapy lensfocused ultrasound may be used to increase the elasticity of sinews andscars, improve the mobility of joints, provide analgesic effects, alterblood flow, and produce muscular spasms. High intensity ultrasound(10-2000 W/cm²) is used for tissue ablation, cutting, fractionation(histotripsy) and for arresting internal bleeding (hemostasis).Historically, piezoelectric and magnetostrictive transducers are widelyused to transform generate a high intensity ultrasound field.

In therapeutic applications the precision targeting of deep tissues isimportant. Desired therapeutic effect must be confined to a small spotwithin the body where temperature elevation is sufficient to create alocalized tissue impact without affecting surrounding tissue and organs.This technique is used to selectively destroy the unwanted tissue withinthe body without perturbing adjacent tissues. Typically, heating thetissue to 60° C.-80° C. results in tissue necrosis, a process commonlytermed as thermal ablation. In most cases, the high intensity focusedultrasound is used in thermal ablation procedures. Ultrasound focusingcan be achieved by having concave focused transducers producingconvergent beams of predetermined geometry and/or by manipulating thedriving electrical signals (phase and amplitude) of multiple activetransducers (Cathignol, 2002, High Intensity Piezoelectric Sources forMedical Applications: Technical Aspects, Nonlinear Acoustics at theBeginning of the 21^(st) Century, 1, 371-378.). Single focused elementsare more economical but require mechanical steering and suffer a loss ofacoustic efficiency due to heating and presence of parasitic surfacewaves (Kluiwstra et al., 1997, Design Strategies for TherapeuticUltrasound Phased Arrays, SPIE International Medical Imaging Symposium,Chapelon et al. Transducers for therapeutic ultrasound, Ultrasound inMed. & Biol., Vol. 26, No. 1, pp. 153-159, 2000).

Ultrasound systems use relatively small, low-power transducers fordiagnostic visualization and large high-power transducers for therapy.Typically, the radiation surfaces of the two types of transducerscoincide and often form a surface of revolution of a conic section:circle, ellipse or parabola. Transducers with large radiating surfacesare used to generate sufficient acoustic power and are expensive tomanufacture. Additionally, the applicability of large concavetransducers is limited to an open field clinical cases, where the sizeof the transducer does not matter, as opposed to the most intra-luminalor intra-cavity applications, where access is limited and thedimensional requirements counter acoustic power and sensitivityrequirements.

SUMMARY OF THE INVENTION

The present invention aims to provide an improved focused ultrasoundtransducer assembly. The transducer of the present invention provides analternative for ultrasound focusing at different depths in a subject forultrasound scanning and therapy.

The present invention in part aims to provide an ultrasound transducerwith a substantially flat radiating shape and an interchangeabledisposable focusing lens to provide an alternative for ultrasoundfocusing at different depths in tissue for ultrasound visualization andtherapy.

This invention is directed in principal part to an apparatus and methodfor applying sonic energy within the body of the living subject. Moreparticularly, this invention is directed in principal part to a probefor applying ultrasound energy within the body of a subject and thatincludes a probe body having a proximal end and a distal end that isadapted for insertion into the body of a subject. The probe furtherincludes an ultrasound transducer disposed proximate to the distal endof the probe body and a device for moving one portion of the transducerrelative to the probe body while the distal end of the probe is disposedwithin the body of the subject. The ultrasound transducer typicallyincludes a set of piezoelectric elements having an essentially flatfront radiating surface. The probe further includes an interchangeablelens for focusing an ultrasound wave. The lens is disposed in the frontof the piezoelectric elements parallel to their radiating surface and ismovable relative to the piezoelectric elements to focus ultrasoundenergy at different locations. A set of piezoelectric elements has anarrangement of electrodes enabling its use for diagnostic investigationsand therapeutic applications.

One aspect of the present invention provides a substantially flat set ofultrasonic transducers conveniently sized for passage into and/orthrough body cavities and lumens and optimized for acoustic powerefficiency to effectively visualize and/or treat internal organs orregions of the body. One form of such transducer includes one or aplurality of discrete transducers elements mounted in a layeredstructure with a substrate or backing layer and with cooling produced bychanneling water through one or more gaps between the layers of thetransducer assembly, the gaps being of predefined size to maximize theforward acoustic power. A further aspect of present invention provides adisposable lens attachable to such a transducer in order to focusultrasound at a single spot or multiple spots for therapeutic anddiagnostic applications. Such a disposable lens can be manufactured at alow cost in a variety of focusing configurations. It shall providedoctors with an additional set of reliable tools to deliver configurableultrasound energy focusing based on a patient's anatomy. One form of thelens variation can be interchangeable Fresnel lenses of substantiallysimilar dimensions designed to focus at different tissue depths. Thedepth of focus can be controlled by a mechanical exchange of differentfocal length lenses or by adjusting the transducer operating frequency.In the latter case, the Fresnel lens changes its depth of focusdepending on the frequency thus offering an elegant way of controllingenergy deposition at different depths when treating large tissue volumesusing a single fixed lens and a set of high-power transducers capable ofoperating at a range, or with a discrete set, of frequencies. Thisoption is particularly attractive because it does not require any deviceconstituent components exchanges and can be fully controlledelectronically. FIG. 24 shows relative intensity profiles created by the8-zones Fresnel at a set of frequencies. The lens was designed to focus4 MHz waves at 40 mm depth. Clearly, the use of 5 MHz frequency movesthe focal zone deeper, outward by about 10 mm, while focal spot isbrought to a shallower depth at 3 MHz. This invention furthercontemplates moving the transducer relative to a lens or both relativeto a probe in order to achieve large volume tissue impact.

As yet another alternative, a field conjugate lens (Lalonde and Hunt,Variable frequency field conjugate lenses for ultrasound hyperthermia,42, 5, 825-831, 1995) for simultaneous focusing of an acoustic field inmultiple locations can provide a volume distributed focal pattern thatcan enable stationary ablation of large tissue volumes.

The present invention contemplates that one or more imaging transducerelements and one or more therapeutic transducer elements are integralparts of a transducer assembly. The imaging and therapeutic transducerelements are either adjacent to and joined to one another or located inclose proximity. The device may further comprise a probe casing, a lens,and a holder. The lens and the transducer module may be mounted to theholder inside the probe casing.

In accordance with a feature of the present invention, a lens and atherapy transducer are mounted to a holder assembly with the lensinserted in front of the transducer to thereby create a desirable focalpattern (spot, multiple spots, line, or spatially distributed pattern)in accordance with a diagnosis of a diseased organ to be treated withtherapeutic ultrasound. The lens according to this aspect of inventionis made of material such as polystyrene, polyethylene, parylene, nylon,or acrylic or combinations thereof, that has a sound speed higher thanthat of water, or Flourinert liquid, contained in a thin wall mold orlow absorption moldable silicone rubbers, such as in RTV-615 family,offering a lens design with sound speed lower than that of water. Thelens may be disposable and has a potential to be geometry compliant to adesired shape and form, if made out of flexible material such assilicone.

Another aspect of this invention includes a lens movable relative to thetransducer to thereby vary the location of a focal zone relative to thetransducer. The movability of the lens facilitates the application ofultrasonic waveform energy to an extended surgical target region. Thelens may be movable in parallel to a planar transducer element, whichfacilitates the targeting of a planar tissue structure.

The lens may constitute a thin sheet not exceeding several ultrasoundwavelengths in thickness and a few times larger than the transducer toexpose different sections of the sheet when it is moved over an activearea of the transducer. The sheet my contain a continuously varyingimprinted lens pattern or a plurality of discretely varying imprintedlens patterns that provide for different focal zones, for example,varying in focal depth, thus enabling simple mechanism to have a devicewith variable focal length. A Fresnel lens larger than the transducermay enable shifting of the focal pattern from one location to another.Alternatively, separate lens patterns can be imprinted on a sheet toenable focusing at different distances and/or angles and producespatially distributed multiple focal spot patterns required for aneffective and fast ablation procedure.

An ultrasonic transducer device in accordance with the present inventioncomprises at least one high-intensity ultrasound transducer element madeof a piezoelectric ceramic material, an acoustic focusing lens, and aholder assembly. The lens and the module are mounted to the holderassembly so that the lens is spaced a predetermined distance from thetransducer element. A liquid layer having a thickness of thepredetermined distance is provided between the lens and the transducerelement.

The flat transducer sandwiched between two lenses with different focaldepth mounted on a holder or fixed parallel to said transducer through awater gap constitute an enabling arrangement to achieve tissue ablationat different depth. The part of the acoustic energy emanated by thetransducer toward the tissue, propagate through a lens and is focused ata depth fully defined by the lens design. The other part of the energyis radiated away from the tissue and blocked by the holder or scatteredinside a water cooled probe.

Pursuant to another feature of the present invention, this devicefurther comprises a solid backing member disposed on a side of thetransducer element opposite the lens. The backing member is spaced by anadditional predetermined distance from the transducer element. A liquidlayer having a thickness of the additional predetermined distance isprovided between the transducer element and the backing member.

Pursuant to a supplemental feature of the present invention, this devicemay also comprise at least one imaging transducer element made of apiezoelectric polymeric material, the imaging transducer element beingbonded to either the high-intensity ultrasound transducer element or thelens. The imaging transducer element may be bonded to a front or rearmajor surface of the high-intensity ultrasound transducer element ordisposed inside a recess therein.

The lens and the transducer element may be mounted to the holderassembly so that the lens is movable relative to the transducer elementto thereby enable one to vary the location of a focal locus relative tothe holder assembly (and concomitantly relative to the patient, with theprobe or holder assembly being held stationary relative to the patient).Where the transducer element has a planar form, the lens may beshiftable in a plane oriented substantially parallel to the transducerelement, thereby enabling a relocating of the focal locus in a planeparallel to the transducer element. Where the lens is rotatable about anaxis, the focal locus may be repositioned along a cylindrical locus.

Pursuant to an additional feature of the present invention, the devicefurther comprises at least one metal member operatively mounted to theholder assembly laterally of the lens so as to block transmission ofultrasonic vibrations along pathways laterally displaced relative to thelens. Where the lens is movable relative to the transducer, the metalmember(s) are stationary with respect to the lens and move therewithrelative to the transducer.

An ultrasonic diagnostic and treatment probe in accordance with anotherfeature of the present invention comprises a casing provided at a distalend with a sidewall having a window, a transducer holder disposed insidethe probe, at least one high-intensity or high-power therapeutictransducer element made of a piezoelectric ceramic and mounted to theholder so as to be juxtaposable to the window, and at least one imagingtransducer element disposed in a region about the window.

It is to be understood that at least the therapeutic transducer elementis disposed in a liquid-filled bladder (bolus) which in turn is disposedmainly inside the casing (but potentially extends out through the windowin the casing). The liquid-filled bladder enables efficient transmissionof ultrasonic pressure waves between target tissues of a patient, on theone hand, and the therapeutic transducer element and possibly theimaging transducer element, on the other hand.

Where the holder is provided with a plurality of faces (for instance,where the holder is in part a right rectangular prism), the holder maybe rotatably mounted in the casing so that different ones of the facesmay be alternately positioned adjacent to and facing the window. In thatcase, the high-intensity or high-power therapeutic transducer elementmay be provided on a first one of the faces, and the imaging transducerelement on a second one of the faces. Accordingly, the mode of operationof the probe may be changed from therapy to diagnostic examination andvice versa in part by rotating the holder to juxtapose the appropriatetransducer element to the window.

The faces of the probe holder are oriented at a non-zero angle relativeto one another. Where the holder includes a right rectangular prism, thetherapeutic transducer element and the imaging transducer element may bedisposed in faces that are parallel, or alternatively perpendicular, toone another.

Alternatively, where the probe casing and the holder each exhibit alongitudinal axis oriented coaxially or in parallel to one another, thehigh-intensity or high-power therapeutic transducer element and theimaging transducer element may be disposed along a common side of theholder. In that event, the holder is longitudinally reciprocatablerelative to the casing so that high-intensity or high-power therapeutictransducer element and the imaging transducer element are alternativelydisposable adjacent the window in the casing.

In another alternative configuration, rather than being provided on aholder inside the casing (and inside the bolus), the imaging transducerelement is provided on the casing in juxtaposition to the window. Thus,one or more imaging transducer elements may be disposed on a distaland/or proximal side of the window, or alternatively along a webintermediate of the window (bisecting the window into two openings).

The imaging transducer element is preferably made of a piezoelectricpolymeric material such as polyvinylidene fluoride (PVDF). Furthermaterials are discussed hereinafter. As indicated, an acoustic Fresnellens may be mounted at least indirectly to the casing adjacent to thewindow for focusing ultrasonic waves from the therapeutic transduceronto a focal locus such as a line or point.

An ultrasonic diagnostic and treatment probe in accordance with yetanother feature of the present invention comprises a casing provided ata distal end with a sidewall having a window, at least onehigh-intensity or high-power therapeutic transducer element made of apiezoelectric ceramic and disposed inside the casing in juxtaposition tothe window, and an acoustic focusing lens mounted at least indirectly tothe casing adjacent to the window.

The lens may be mounted to the casing so that the lens is movablerelative to the transducer element, thereby varying the location of afocal locus relative to the casing. For instance, the lens may beshiftable parallel to a longitudinal axis of the casing, therebyenabling a relocating of the focal locus in a plane parallel to thetransducer element. Alternatively or additionally, the lens may berotatable about an axis parallel to a longitudinal axis of the casing,thereby enabling a relocating of the focal locus along a cylinder.

The transducer element may be planar or cylindrical, and the lens may becylindrical or spherical.

Pursuant to the above-described embodiments of the present invention,the invention provides in part a multifocal dual mode ultrasonictransducer for use in a medical therapy and imaging apparatus.

The multifocal ultrasonic transducers of the present invention may beused in a diagnostic mode, applying ultrasonic energy within a body ofliving subject for visualization of body internal organs, andalternately in a therapeutic mode, implementing thermal ablation,hyperthermia, transfection and/or drug delivery. An imaging transducerelement as used in the present invention may be made of polymericpiezoelectric materials. Suitable polymeric materials for imagingtransducer elements include polyvinylidene fluoride (PVDF), andcopolymers of PVDF such as trifluoroethylene (TrFE) with a piezoelectricvoltage constant g₃₃>100×10⁻³ Vm/N. Piezoceramic materials suitable fortherapy transducer elements include modifications of BaTiO₃, Pb(Ti,Zr)O₃(PZT) and PbNb₂O₆ ceramics with a high piezoelectric strain constant,d₃₃>200×10⁻¹² m/V.

Pursuant to an additional feature of the present invention, the devicefurther comprises at least one flat transducer assembly element axiallysymmetrically mounted to the rotatable holder assembly and enclosedbetween the focusing lenses on both sides so as to focus ultrasoundenergy on one side and block transmission of ultrasonic vibrations onthe other side by means of probe holder that permits energy propagationto the tissue along the predefined pathways. The focal depth of suchassembly can be easily change by rotating the transducer-lens assembly180 degrees inside the holder assembly.

Yet another feature of phase discrete lenses is the ability to changethe focal depth with operating frequency. It can be utilized to produceablation patterns at different depth and enhance treatment of largetissue volumes. For example, the lens designed to operate at 4.0 MHz at40 mm depth will focus at a deeper depth when operated at frequencyexceeding 4.0 MHz. Alternatively a lens can be constructed of the slowmaterials, such as, for example the Flourinert liquid, and will focusdeeper at higher frequencies, thus being especially attractive for thehigh resolution imaging applications, which can selectively utilizedifferent frequencies for visualization and targeting of organs locatedat different depths. For small variation of operating frequency f fromthe lens design frequency f₀ the focusing depth of a lens can beexpressed as F=F₀f₀/f, where F₀ is the focal depth at the designfrequency f₀. A combination of Fresnel lens and multiple transducer set,each of which coincides with an area of a single Fresnel zone, providesan ability to perform multiwave imaging and improve an imagingresolution for deep seated organs. The higher frequency signals comingfrom deeper depth will be focused by a lens to the respective arrayreceiving elements and processed. This is especially attractive for themonitoring of the cavitation and tissue erosion processes accompanied byan emission of broad spectrum and higher frequency harmonics indicativeof lesion formation and location in application of high intensityfocused ultrasound.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic cross-sectional view of a dual mode transducerassembly in accordance with the present invention, showing a backinglayer.

FIG. 2 is a schematic cross-sectional view of yet a further dual modetransducer assembly in accordance with the present invention, showing abacking layer.

FIG. 3 is a schematic cross-sectional view of another dual modetransducer assembly in accordance with the present invention, showing abacking layer.

FIG. 4 is a circuit diagram incorporating a dual mode transducer, inaccordance with the present invention.

FIG. 5 is a schematic cross-sectional view of another dual modetransducer assembly in accordance with the present invention.

FIG. 6 is a schematic cross-sectional view of an alternate dual modetransducer assembly in accordance with the present invention.

FIG. 7 is a is a schematic cross-sectional view of a transducer assemblyor device having a Fresnel lens in accordance with the presentinvention, showing a holder for the transducer and lens assembly.

FIG. 8 is a schematic cross-sectional view of a transducer assembly witha relatively shiftable Fresnel lens, in accordance with the presentinvention.

FIG. 9 is a schematic side elevational view of a dual mode transducerassembly with a rotatable holder, in accordance with the presentinvention.

FIG. 10 is a schematic perspective view of another dual mode transducerassembly with a rotatable holder, in accordance with the presentinvention.

FIG. 11 is a schematic perspective view of a dual mode transducerassembly with a reciprocatable holder, in accordance with the presentinvention.

FIG. 12 is a schematic perspective or isometric view of a dual modetransducer assembly with an imaging transducer element disposed on acasing, in accordance with the present invention.

FIG. 13 is a schematic perspective or isometric view of a dual modetransducer assembly with two imaging transducer elements stationaryrelative to a casing, in accordance with the present invention.

FIG. 14 is a schematic partial perspective or isometric view of atransducer assembly with a tiltable and longitudinally positionablespherical Fresnel lens, in accordance with the present invention.

FIG. 15 is a schematic transverse cross-sectional view of the transducerassembly of FIG. 22.

FIG. 16 is a schematic transverse cross-sectional view similar to FIG.23, showing an alternative transducer assembly.

FIG. 17 is a schematic partial perspective view of a cylindrical Fresnellens included in the transducer assembly of FIG. 16.

FIG. 18 is a schematic perspective view of an ultrasound transducerassembly in accordance with the present invention, including anultrasound transducer and a Fresnel lens with a focal length gradientalong one major dimension.

FIGS. 19A-19C are a series of diagrams showing variation in a focallength as a function of relative position of the transducer and Fresnellens of FIG. 18.

FIG. 20 is schematic cross-sectional view of another ultrasoundtransducer assembly in accordance with the present invention, includinga transducer element and a Fresnel lens having a plurality of discretesections of different focal lengths.

FIG. 21 is a schematic perspective view of yet a further ultrasoundtransducer assembly in accordance with the present invention, includinga transducer element and a generally cylindrical Fresnel lens elementhaving a focal length that varies in a continuous gradient around acircumference of the lens.

FIG. 22 is a graph of focusing effectiveness as a function of distancefrom a 2-zone 4 MHz Fresnel lens as a function of three acousticfrequencies.

FIG. 23 is a graph of focusing effectiveness as a function of distancefrom a 4-zone 4 MHz Fresnel lens as a function of three acousticfrequencies.

FIG. 24 is a graph of focusing effectiveness as a function of distancefrom an 8-zone 4 MHz Fresnel lens as a function of three acousticfrequencies.

FIG. 25 is a perspective view of a flat-pack HIFU head assembly inaccordance with the present invention.

FIG. 26 is an end elevational view of the HIFU head assembly of FIG. 25.

FIG. 27 is a longitudinal cross-sectional view taken along lineXXVII-XXVII in FIG. 26.

FIG. 28 is a schematic cross-sectional view of a piezoelectrictransducer showing vibration modes at the top and metal supports orelectrodes at the bottom for damping modes of vibration.

FIG. 29 is a schematic perspective view of a cylindrical transducer andassociated cylindrical lens in accordance with the present invention.

FIG. 30 is a schematic end view of the transducer and lens of FIG. 29,showing an associated focal locus.

FIG. 31 is a diagram showing wavefronts of two different frequenciesdirected to respective focal points by a Fresnel lens.

FIG. 32 is a schematic perspective view of another flat-pack HIFU headassembly in accordance with the present invention.

FIG. 33 is a cross-sectional view of the assembly of FIG. 32.

FIG. 34 is a schematic cross-sectional view of another transducerassembly in accordance with the present invention, showing an imagingtransducer disposed at an inactive position relative to a focusing lens.

FIG. 35 is a schematic cross-sectional view of the transducer assemblyof FIG. 34, showing the imaging transducer disposed at an activelocation aligned with a central region of the focusing lens.

FIG. 36 is a pair of graphs, the first graph showing power transmissionthrough a Fresnel lens as a function of radius, the second graph showingphase shift as a function of radius.

DETAILED DESCRIPTION

As shown in FIG. 1, a dual mode ultrasound transducer assembly or device148 may comprise a single piezoelectric ceramic transducer element 150that serves in part as a substrate to one or more piezoelectricpolymeric transducer elements 152 bonded to a major face 154 of theceramic transducer element 150 on a front side thereof, opposite abacking layer 156. Ceramic transducer element 150 functions in a therapymode of operation to generate high-intensity ultrasonic mechanicalvibrations that are transmitted to a desired surgical site inside anorgan of a patient. Likewise, polymeric transducer element or elements152 function in a diagnostic mode of operation to detect incomingultrasonic pressure waves that are processed to generate image data asto tissue and organ structures of the patient primarily in a regionclosely about the target surgical site. An acoustic lens 157 may beprovided on the front side of transducer 148 (which has a planar frontradiating face), opposite backing 156 for focusing at least thetherapeutic ultrasonic pressure waves at a focal point (spherical lens)or along a focal line (cylindrical lens). In that case, a single imagingtransducer element 150 is provided, which is located in alignment with acenter region of lens 157. Lens 157 may be a concave lens, a convexlens, a Fresnel lens, a Fresnel multilevel lens, or a Field Conjugatelens.

As shown in FIG. 2, in a modification of ultrasound transducer assembly148 of FIG. 9, a dual mode ultrasound transducer assembly or device 158has a single piezoelectric ceramic transducer element 160 serving inpart as a substrate to one or more piezoelectric polymeric transducerelements 162 that are bonded to a major face 164 of the ceramictransducer element 150 on a rear side thereof, facing a backing layer166. The one or more polymeric transducer elements 162 extend intorespective recesses 168 formed in backing layer 166. Ceramic transducerelement 160 and polymeric transducer element or elements 162 function inalternate operating modes as discussed above. As above, an acoustic lens167 may be provided on the front side of transducer 158 (which takes aplanar form having a planar front radiating face), opposite backing 166for focusing at least the therapeutic ultrasonic pressure waves at afocal point (spherical lens) or along a focal line (cylindrical lens).In that case, a single imaging transducer element 162 is provided, whichis located in alignment with a center region of the lens. Lens 167 maybe a concave lens, a convex lens, a Fresnel lens, a Fresnel multilevellens, or a Field Conjugate lens.

Backing layers 156 and 166 serve in part to reflect ultrasonic pressurewaves. Ceramic transducer elements 150 and 160 are spaced from backinglayers 156 and 166, respectively, by liquid layers 170 and 172(typically water or saline) of a thickness selected to facilitateultrasonic pressure wave transmission, as discussed hereinafter.Likewise, lenses 157 and 167 are spaced from ceramic transducer elements150 and 160, respectively, by liquid layers 174 and 176 of a thicknessselected to facilitate ultrasonic pressure wave transmission.

As shown in FIG. 3, in another modification of dual mode ultrasoundtransducer 148 of FIG. 9, a dual mode ultrasound transducer assembly ordevice 178 has a single piezoelectric ceramic transducer element 180that serves in part as a substrate to a piezoelectric polymerictransducer elements 182 disposed inside a hole 183 in the ceramictransducer element 180 on a front side thereof, facing away from abacking layer 186. An epoxy or solid metal plug 188 is also disposed inhole 183, on a rear side, facing backing layer 186. As discussed abovewith respect to ultrasound transducer 148 of FIG. 9, ceramic transducerelement 180 and polymeric transducer element or elements 182 function ina therapeutic and an imaging operating mode, respectively. As above, anacoustic lens 190 may be provided on the front side of transducer 180(which takes a planar form), opposite backing 186 for focusing at leastthe therapeutic ultrasonic pressure waves at a focal point (sphericallens) or along a focal line (cylindrical lens). Lens 190 may be aconcave lens, a convex lens, a Fresnel lens, a Fresnel multilevel lens,or a Field Conjugate lens.

FIG. 4 is a circuit diagram applicable to any of the dual modepiezocomposite transducers described herein. As shown in FIG. 12, one ormore piezoelectric ceramic transducer elements 192 and one or morepiezoelectric PVDF transducer elements 194 are connected in parallel toa source of high-intensity alternating voltage 196 and to a filter 198having an output extending to an analog-to-digital converter 200 andfrom thence to an ultrasonic signal processor 202.

A relatively low driving voltage applied by source 196 to ceramictransducer elements 192 in a therapy mode does not engage PVDFtransducer elements 194. PVDF transducer elements 194 have asubstantially higher electrical impedance than the impedance of ceramictransducer elements 192 so that the total electrical impedance of theparallel circuit of FIG. 12 quite similar to that of ceramic, so thatthe presence of PVDF elements 194 in the circuit consequently has littleeffect on electrical power transfer and produced acoustic power. In animaging mode, the low acoustic impedance of the PVDF transducer elements194 provide broad band signals in response to received echoes due to thehigher sensitivity of PVDF material relative to ceramic, while ceramictransducer elements 192 reflect most of the incoming acoustic energy dueto high impedance contrast in an absence of acoustic matching layers.

Ceramic transducer elements 192 and polymeric transducer elements 194can share the same electrodes or be connected to different electrodes.The number of individual therapeutic ceramic transducer elements 192 andimaging polymeric elements transducer elements 194 depends on theapplication.

If a PVDF transducer element 194 is used to send and receive acousticsignals as it is done in a standard pulse-echo imaging systems, thenthere is a need to couple that PVDF transducer to both a high-voltageexcitation pulse generator (not separately shown) and the sensitivereceiving electronics, i.e., ultrasonic signal processor 202. Atransmit-receive (T/R) switching circuit (not shown) that would closeduring the application of a higher voltage signal but open while theprobe is receiving acoustic echoes can be used. Alternatively, one mayuse a circuit designed to send acoustic signals using one or morepiezoceramic transducer elements 192 and receive echoes with PVDFtransducer elements 194. This is feasible, because of close packedinterpenetrant nature of piezocomposite transducers disclosed herein andconsequent negligible differences in beam directivity between ceramicand polymer elements.

FIG. 5 depicts a dual mode transducer assembly 204 including apiezoceramic therapy transducer element 206 and an acoustic lens 208spaced from one another by a liquid layer 210. Lens 208 is a Fresnellens is provided in a central region with a piezoelectric polymericimaging transducer element 212. Transducer element 212 occupies athrough hole 214 in the lens. A backing layer 213 is paced by a liquidlayer 215 from a back side of ceramic transducer element 206.

FIG. 6 shows a modification 216 of the dual mode transducer assembly ofFIG. 13. Dual mode transducer assembly 216 includes a piezoceramictherapy transducer element 218 and an acoustic lens 220 spaced from oneanother by a liquid layer 222. Lens 220 is provided in a central regionwith a piezoelectric polymeric imaging transducer element 224.Transducer element 224 is disposed in a recess 226 on a rear side oflens 220, facing ceramic transducer element 218 and a backing layer 219.Lens 220 may be a concave lens, a convex lens, a Fresnel lens, a Fresnelmultilevel lens, or a Field Conjugate lens.

Backings 156, 166, 186, and backing layers (not illustrated) in dualmode transducer assemblies 204 and 216 of FIGS. 5 and 6 may be made ofsuch a material as brass or SiC. Ceramic transducer elements 150, 160,180, 206, and 218, as well as backings 156, 166, 186, and backing layers(not illustrated) in dual mode transducer assemblies 204 and 216 ofFIGS. 5 and 6, are mounted to respective casings or holder members, asdiscussed below with reference to FIG. 7. Accordingly, it is to beunderstood that all transducers disclosed herein are typically providedas integrated parts of ultrasound probes, mounted inside liquid-filledbladders or boluses that in turn are disposed at least in part insiderigid probe casings.

As illustrated in FIG. 7, an ultrasound transducer assembly 228 includesa planar piezoceramic therapy transducer element 230, a backing 232, andan acoustic lens 234 (e.g., a concave lens, a convex lens, a Fresnellens, a Fresnel multilevel lens, or a Field Conjugate lens) that areconnected to one or more mounting members 236, 238 and disposed inside aflexible bladder 240 that is in turn disposed inside a casing 242provided with a window 244. Casing 242 and the contents thereof comprisea probe for high-intensity focused ultrasound (HIFU) surgical therapy.

Lens 234 is spaced from transducer element 230 by a distance d₁ equal to(2n+1)λ/4 where n is a non-negative integer and λ is the wavelength ofthe ultrasonic pressure waves for therapeutic applications. Transducerelement 230 is spaced from backing 232 by a distance d₂ equal to nλ/2where again n is a non-negative integer and λ is the wavelength of theultrasonic pressure waves for therapeutic applications.

As depicted in FIG. 8, an ultrasound transducer assembly 246 at leastfor use in a therapy mode comprises a planar piezoceramic transducerelement 248, a backing layer 250, and an acoustic lens 252 (a concavelens, a convex lens, a Fresnel lens, a Fresnel multilevel lens, or aField Conjugate lens) aligned with one another and spaced byliquid-filled gaps 254 and 256 of thickness d₁ and d₂, respectively. Twometal plates 258 and 260, which serve to block ultrasonic wavetransmission, are connected to lens 252 on opposing sides thereof. Lens252, together with metal blockers 258 and 260, is longitudinallyshiftable alternately in opposite directions, as indicated by doubleheaded arrow 262, relative to transducer element 248 for enabling a userto move a focal zone of the ceramic transducer. Lens 252 may be acylindrical lens, in which case the focal zone or locus (set of points)is a line. Moving the lens 252 relative to the transducer 248 (and probecasing, not shown) shifts the focal locus along a plane parallel to thetransducer and thus parallel to an organ surface against which thetherapy probe lies. Metal blockers 258, 260 prevent ultrasonic pressurewaves from radiating into the patient except towards the focal locusdefined in part by lens 252. Any of the lenses disclosed herein may bemovably mounted relative to the respective ceramic transducer element tofacilitate application of focused high-intensity ultrasound to anextended target site.

FIG. 9 depicts a dual mode transducer assembly 264 with a rotatableholder 266, as indicated by an arrow 268. Holder 266 includes a head 270in the form of a right rectangular prism. Head 270 is provided on oneface 272 with at least one high-power ceramic transducer element 274that is either planar or shaped for focusing. In the case of a planartransducer element 274, an acoustic lens (not shown) is provided forfocusing the planar ultrasonic waves from transducer onto a focal locussuch as a point (spherical lens) or a line (cylindrical lens). Anotherface 276 of head 270 carries at least one planar or focally shapedpiezoelectric polymeric (e.g., PVDF) transducer element 278. In the caseof a planar transducer element 278, an acoustic lens (not shown) may beprovided for focusing the planar ultrasonic waves from a focal locusonto transducer element 278. Where the ultrasonic pressure wavesgenerated by ceramic transducer element 274 for therapy have a frequencythat is substantially different than the frequency of pressure waves forimaging, two different lenses may be provided. The lens may be shiftablymounted to a probe casing (not shown) for alternate use during therapyand imaging operations.

As in the case of other transducer devices described above, the dualmode transducer assembly 264 of FIG. 9 is typically incorporated into anultrasound probe including a casing and bolus. More particularly, holder266 is disposed inside a liquid-filled bladed or bolus (not shown) thatin turn is disposed inside a probe casing (not shown) in juxtapositionto a window in the probe casing. As discussed above, transducer elements274 and 278 are used in alternation in therapeutic and imaging operatingmodes, respectively. Holder 266 is rotated in order to juxtaposetransducer element 274 to the casing window during a period of therapyapplication and subsequently to juxtapose transducer element(s) 278 tothe casing window during an imaging interval.

FIG. 10 depicts a modification 280 of the dual mode transducer assembly264 of FIG. 9 and uses the same reference numerals to designate the sameparts. In transducer assembly 280, ceramic transducer element 274 andpolymeric transducer element 278 are located in adjacent faces 272 and282, rather than opposite faces 272 and 276 as in transducer assembly264 of FIG. 9. Accordingly, the operation is slightly altered inasmuchas holder 266 need be rotated only 90° rather than 180° to change fromtherapy mode to imaging mode and vice versa.

As shown in FIG. 11, a dual mode transducer assembly 284 has alongitudinally reciprocatable holder 286, as indicated by adouble-headed arrow 288. Holder 286 includes a head 290 in the form of aright rectangular prism or plate. Head 290 is provided on one face 292with both a planar or shaped high-power ceramic transducer element 294and a planar or shaped piezoelectric polymeric (e.g., PVDF) transducerelement 296. In the case that transducer elements 294 and/or 296 areplanar, one or more acoustic lenses (not shown) may be provided forfocusing purposes. Again, holder 286 is disposed inside a liquid-filledbladed or bolus (not shown) that in turn is disposed inside a probecasing (not shown) in juxtaposition to a window 298 in the probe casing.Transducer elements 294 and 296 are alternately juxtaposed to the casingwindow 298 to implement therapeutic and imaging operating modes,respectively, by shifting holder 286 in a distal or proximal directionas appropriate.

FIG. 12 shows a dual mode transducer assembly 300 including a probecasing 302 provided at a distal end with a window 304 in a sidewall (notseparately designated) and further including a piezoceramic transducerelement 306 in a holder 308 disposed inside the casing. A piezoelectricpolymeric imaging transducer element 310 is disposed in window 304 andlocated along an arcuate bridge (not separately designated) so as tobifurcate the window. A bolus or bladder member 312 is provided outsideof casing 302 and may be pressurized to expand from a partially inflatedstorage configuration (not shown) to a fully inflated use configurationas shown.

FIG. 13 illustrates a dual mode transducer assembly 314 including aprobe casing 316 provided in a sidewall (not separately designated) at adistal end with a window 318. A planar or focally shaped piezoceramictransducer element 320 is disposed on a holder 322 inside casing 316.Two piezoelectric polymeric imaging transducer elements 324 and 326,disposed along distal and proximal sides of window 318, are configuredfor scanning tissues at a focal zone 327. A bolus or bladder member 328is provided outside of casing 316 and may be pressurized to expand froma partially inflated storage configuration (not shown) to a moreexpanded use configuration as indicated.

Pursuant to FIGS. 14 and 15, an ultrasound transducer assembly 330includes a probe casing 332 provided in a sidewall (not separatelydesignated) at a distal end with a window 334. A piezoceramic transducerelement 336 is disposed on a holder 338 inside casing 332. Also disposedon a holder 340 inside casing 332 is a spherical acoustic Fresnel lens342. As indicated by an arrow 344 in FIG. 15, holder 340 and Fresnellens 342 are rotatable about a longitudinal axis 346, whereby a focalpoint of the lens moves along an arc. In addition, holder 340 and lens242 may be longitudinally reciprocatable, as indicated by adouble-headed arrow 348, so that the focal point of the lens may bemoved distally and proximally. A bolus or liquid-filled bladder (notshown) is provided about the casing 332.

Lens 342 may be flanked by metal plates (not shown) for limitingultrasound irradiation.

As depicted in FIGS. 16 and 17, an ultrasound transducer assembly 350includes a high-power therapy transducer 352 in a parabolic orcylindrical configuration, on a holder 354 inside a probe casing 356.Transducer element 352 is disposed so that its axis extends in adistal-proximal direction, parallel to a longitudinal axis 358 of theprobe casing. Ultrasound transducer assembly or probe 350 furtherincludes a cylindrical acoustic Fresnel lens 360 that is oriented withits axis transverse to the axis of transducer element 352, therebyproducing a focal zone or locus that is a point. As indicated, lens 360may be rotatable and optionally longitudinally shiftable, for shiftingthe location of the focal point relative to the probe and accordinglyrelative to a patient.

Polymeric piezoelectric materials suitable for imaging transducerelements 152, 162, 182, 212, 194, 224, 278, 296, 310, 324, and 326include polyvinylidene fluoride (PVDF), and copolymers of PVDF such astrifluoroethylene (TrFE) with a piezoelectric voltage constantg₃₃>100×10⁻³ Vm/N. Piezoceramic materials suitable for therapytransducer elements 150, 160, 180, 206, 192, 218, 230, 248, 274, 294,306, 320, and 336 include modifications of BaTiO₃, Pb(Ti,Zr)O₃ (PZT) andPbNb₂O₆ ceramics with a high piezoelectric strain constant,d₃₃>200×10⁻¹² m/V.

Imaging transducer elements as used herein are derived from anappreciation of the properties of polyvinylidene fluoride (PVDF). Thatpolymer is a semi-crystalline, thermoplastic fluoroplastic. It hasreceived a considerable research attention in past decades that stemsfrom the discovery of its piezoelectric and pyroelectric properties andits subsequent application as an electret and piezoelectric transducer.With its low acoustic impedance of 3.5 MRyals and high voltage constantPVDF makes an ideal ultrasound receiver and shows definite advantagesover ceramic counterparts. As a transmitter of acoustic power, the PVDFtransducer is quite poor, but its enhanced sensitivity on receptionprovides a send-receive factor comparable to that of ceramic. The tablebelow summarized common applications and lists relevant piezoelectricproperties for typical piezoelectric ceramic, quartz and PVDF.

Piezoelectric material properties (Gallentree, 1983, Review ofTransducer Applications of Polyvinylidene Fluoride, Piezoelectricity,Key Paper in Physics, 189-194; Kino, 1987, Acoustic Waves: Devices,Imaging, and Analog Signal Processing, Prentice Hall, Englewood Cliffs,NJ, Appendix B; Mason, 1966, Physical Acoustics: Principles and Methods,edit Rosenberg, Mir, Moscow) d₃₃, g₃₃, Curie m/V Vm/N Applications T, °C. Q_(m) 10⁻¹² 10⁻³ Navy STM, nanopositioning, 328 500 289 25 Type Imedical therapeutics. (PZT4) Navy flow and level sensing 365 75 374 25Type II and medical Doppler (PZT5A) transducers Navy Ultrasoniccleaners, 300 1000 225 25 Type III cell disruption, (PZT8)phacoemulsification, and high power ultrasonics Navy Medicaldiagnostics, 193 65 593 20 Type VI industrial NDT, (PZT5H) STM/AFM, andnano-Positioning PVDF Insulation (Kynar ®), 100 13 20 210 key boards,sonar hydrophones, pulse-echo ultrasonic transducers Quartz crystalclock oscillator, — 25000 2 50 mass microbalance, and thin-filmthickness monitoring

A typical PVDF transducer does not require cumbersome acoustic matchinglayers, inherent in ceramic transducers, and is relatively easy toproduce in a variety of forms and may be press fit into a curved shape.

Polymeric imaging transducer elements 152, 162, 182, 212, 224, 278, 296310, 324, and 326 are operatively connected to ultrasound imageprocessor 202 or other appropriate waveform processing and digital imagegeneration apparatus, as well known in the art. Ceramic therapytransducers 150, 160, 180, 206, 192, 218, 230, 248, 274, 294, 306, 320,and 336 may operate in part to generate outgoing scanning waveforms.Where there are moving parts, such as lenses moving relative to therapytransducers, the motion may be implemented via electric motors, steppermotors, linear motors, etc., and the motion may be monitored by feedbacksensors such as encoders, voltage dividers, etc.

Ceramic transducer elements 150, 160, 180, 206, 192, 218, 230, 248, 274,294, 306, 320, and 336 function in a therapy mode of operation of therespective transducer assembly or device to generate high-powerultrasonic pressure waves, in response to a suitable energizing signal,that are transmitted into a patient for implementing or assisting in asurgical operation such as thermal ablation, hyperthermia, transfectionand/or drug delivery. Polymeric transducer elements 152, 162, 182, 212,224, 278, 296 310, 324, and 326 function in a diagnostic or scanningmode of operation of the respective transducer assembly or device todetect incoming ultrasonic pressure waves that are reflected frominternal tissue structures of a patient in response to a suitablescanning wave. As discussed above with reference to FIG. 4, thetherapeutic ceramic transducer elements and the diagnostic polymerictransducer element may be connected in parallel in the same circuit.

Thus, the ultrasound transducer devices described herein are providedwith electrical contacts (not shown) enabling a connection of therespective ceramic transducer elements 150, 160, 180, 206, 192, 218,230, 248, 274, 294, 306, 320, and 336 in operative circuits forgenerating, for example, high-intensity focused ultrasound and enablinga connection of the respective polymeric transducer elements 152, 162,182, 212, 224, 278, 296 310, 324, and 326 in operative circuits forscanning organic tissues to generate ultrasonic scan data for analysisand processing into images.

FIG. 18 depicts a Fresnel lens 402 that is reciprocatable along a givendirection, as indicated by a double-headed arrow 404, in parallel to aplanar front radiating face 406 of a flat transducer element 408. Lens402 is spaced from front face 406 of transducer element 408 by a gap 409of a thickness (2n+1)λ/4 where n is a non-negative integer and λ is thewavelength of the ultrasonic pressure waves for therapeuticapplications. Transducer element 408 is spaced from a backing (notshown) by a distance nλ/2 where again n is a non-negative integer and λis the wavelength of the ultrasonic pressure waves for therapeuticapplications.

Lens 402 is configured to have a focal length that varies in acontinuous gradient from a maximum focal length f₁ at one end 410 of thelens to a minimum length f₂ at an opposite end 412 of the lens. Asdepicted in FIG. 19A, a focal zone 414 is disposed at a maximum distanceD₁ (approximately length f₁) from lens 402 when transducer element 408is aligned with the first end 410 of the lens. When transducer element408 is aligned with the opposite end 412 of lens 408, ultrasound wavesconverge at a focal zone 416 located at a minimum distance D₂(approximately length f₂) from lens 402, as shown in FIG. 19C. Whentransducer element 408 is aligned with a middle region of lens 408 asshown in FIG. 19B, ultrasonic pressure waves generated in a subjectconverge at a focal zone 418 disposed at an intermediate distance D₃from lens 402. Accordingly, by moving lens 402 in the direction of arrow404 one focuses destructive ultrasound energy at target regions or focalzones 414, 416, 418 located at different depths D₁, D₂, D₃ in thepatient and at different laterally staggered positions along a skin orinternal surface. As indicated in FIG. 19C, generation of ultrasoundenergy by transducer element 408 while lens is moving from right to leftrelative to the transducer can produce a continuous elongate region 420of therapeutically damaged tissue.

FIG. 20 shows a transducer element 422 ensconced in a backing layer 424and spaced from a Fresnel lens 426 by a liquid-filled gap 428 ofthickness (2n+1)λ/4 where n is a non-negative integer and λ is thewavelength of the ultrasonic pressure waves for therapeuticapplications. Lens 426 comprises a plurality of adjacent sections 430,432, 434 each of a respective focal length s₁, s₂, s₃. Focal lengths s₁,s₂, s₃ are shown to vary in a monotonically decreasing sequence.However, any arrangement of any practicable number of sections ofdifferent focal lengths may be made.

The distance (generally s₁, s₂, s₃) of a target tissue mass or focalzone 438, 440, 442 from lens 426 varies in accordance with which lenssection 430, 432, 434 is in alignment with transducer element 422. Inaddition, limited lateral motion of lens 426 (see arrow 444) relative totransducer 422 while any given lens section 430, 432, 434 remains inalignment with transducer element 422 will shift the respective focalzone 438, 440, 442 laterally in parallel to lens 426 and transducerelement 422 (assuming planar configurations of both).

As illustrated in FIG. 21, an ultrasound transducer assembly 446includes a transducer element 448 on a holder (not separatelyillustrated) disposed inside a generally cylindrical or tubular Fresnellens 450 which has a focal length that varies in a continuous gradient(or, alternatively, in discrete steps) around the circumference of thelens. Thus rotating lens 450 relative to transducer element 448, asindicated by an arrow 454, enables one to target a tissue mass at acontrollably variable depth or distance from assembly 446. Shifting lens450 longitudinally (arrow 452) relative to transducer element 448enables one to vary the position of the focal zone or target tissueregion in the direction of arrow 452.

The depth of focus can be controlled by adjusting the transduceroperating frequency. In the latter case, the Fresnel lens changes itsdepth of focus depending on the frequency thus offering an elegant wayof controlling energy deposition at different depths when treating largetissue volumes using a single fixed lens and a set of high-powertransducers capable of operating at a range, or with a discrete set, offrequencies. FIGS. 23-24 shows relative intensity profiles created by a2-zone Fresnel lens, a 4-zone Fresnel lens and an 8-zone Fresnel lens ata set of three frequencies. The 8-zone lens of FIG. 24 was designed tofocus 4 MHz waves at 40 mm depth. Clearly, the use of a 5 MHz frequencymoves the focal zone deeper, outward by about 10 mm, while the focalspot is brought to a shallower depth at an operating frequency of 3 MHz.The transducer is moved relative to a lens or both are moved relative toa probe in order to achieve large volume tissue impact.

FIGS. 25-27 are a particular configuration of a probe head of a HIFUtreatment device showing a housing 456, a Fresnel lens 458, arectangular piezoelectric transducer 460, a reflector 462, and mill-maxspring-loaded pins 464.

FIG. 28 shows a planar piezoelectric transducer element 466 affixed atopposite ends 468 and 470 to a housing or frame (not shown) and providedwith three metal supports 472-474, optionally in the form of electrodes.Supports 472 and 472 are positioned at the nodes of vibration mode 1,while support 473 is positioned at the node of vibration mode 0. FIGS.29 and 30 depict a HIFU transducer assembly or device including acylindrical transducer element 476 operating in wall thickness mode andan essentially cylindrical Fresnel lens 478 having an azimuthallyvariable focal length, the transducer element being located inside thelens. FIG. 30 shows a variable-depth focal zone 480 about the lens 478.

FIG. 31 shows a lens L constructed to focus planar acoustic waves offrequency f₁ at a focal point F₁. The line Ψ constitutes a constructionline. The solid arcs with the center of origin F₁ are the phase frontsspaced apart by one wavelength λ₁ from each other. The first solidcircle is tangent to the line Ψ not shown. The intersection of solidcircles with line Ψ marks the location of the respective Fresnel zones.At a higher frequency f₂ the acoustic wavelength becomes smaller: λ₂<λ₁.If lens L design is fixed, passing a higher frequency waves through lensL is similar to having the phase circles spaced apart by a smallerdistance λ₂, shown by dashed arcs. In order to focus the dashed arcs,which correspond to frequency f₂>f₁, must intersect the line Ψ at thesame points as solid arcs, which correspond to the original lensfrequency f₁. Clearly, on average dashed arcs can intersect line Ψ atthe same points if their center of origin F₂ is located farther awayfrom the line Ψ than F₁. Using this geometrical construction andneglecting terms of the second order in wavelength an approximateformulae that related the focal depth of a lens and operating frequencyis: F=F₁f₁/f₂. This equation predicts the focal distances for therelatively small number of the Fresnel zones and for the cases wherewavelength is much smaller than focal distances F. For example, goingfrom 4 MHz to 5 MHz would result in a shift of the focal spot from 35 mmto approximately 43 mm, in good agreement with FIG. 22 field simulationresults. Thus, the higher frequency will focus deeper and, respectively,lower frequency will focus at shallower depth than original frequency.

By constructing a lens made of relatively soft silicone, like RTVrubber, one can achieve the limited field transformation effects withoutchanging frequency of transducers. For example, simulation shows that30% stretch in one direction results in a field blurring and slightdepth decrease. This effect can be used to control the volume ofultrasonic energy deposited by a transducer and focused by deformablelens. There is a potential to ablate larger tissue volume with a fieldthat is less focused, yet has sufficient intensity. Stretching the lensis a simple and controllable process that will enable blurring of thefocal intensity zone over larger volume, which can be beneficial forlarge tumor ablations.

FIGS. 32 and 33 show a flat circular configuration for a probe head of aHIFU treatment device, including a housing 482, a Fresnel lens 484, arectangular piezoelectric transducer 486, a reflector 488, mill-maxspring-loaded pins 490, and a center electrode 492.

Another aspect of the present invention, depicted in FIGS. 34 and 35,includes an ultrasound imaging transducer or transducer array 502movable relative to a therapeutic transducer element or array 504 tothereby obtain an image of a region exposed to high power ultrasoundgenerated by the therapeutic transducer element or array and ensure acontrolled and safe therapy process. The movability of imagingtransducer or transducer array 502, as represented by double headedarrow 506 in FIG. 35, facilitates the application of the high powerultrasonic energy to an extended surgical target region.

As shown in FIGS. 34 and 35, therapeutic transducer element or array 504takes a planar form and a Fresnel focusing lens 508 is held by a casingor frame 516 in position parallel to element or array 504, separated bysmall water gap 510. The water or other suitable liquid in gap 510facilitates the cooling of therapeutic transducer element or array 504and serves as a pathway for the introduction of imaging transducer orprobe 502.

Imaging transducer or array 502 may constitute a thin plate notexceeding in thickness the width of gap 510 between therapy transducer504 and lens 508 and having transverse dimensions comparable to a firstor innermost or central Fresnel zone 512 of the lens. Fresnel zone 512is the thinnest part of lens 508 and enables efficient and losslesstransmission and reception of ultrasound by imaging transducer 502, whenthat transducer element or array is positioned in alignment with thecentral or innermost Fresnel zone 512 as depicted in FIG. 35.

Imaging transducer 502 may contain several layers of acoustical matchinglayers, active piezo-materials, bonding and backing layers, constitutinga stacked design, or made of piezo-composite material, which can containa single or plurality of discretely imprinted electrodes that providefor a single element probe or imaging phased array configuration, thusenabling imaging at variable focal depths.

The middle section of Fresnel lens zone 512 is thinner than an outermostsection 514 that has the minimum thickness:

${d \geq \frac{1}{f\left( {\frac{1}{c_{w}} - \frac{1}{c_{m}}} \right)}},$

where c_(w) and c_(m) are the sound speed in water and lens material,respectively, and f is the frequency. Thus innermost or central Fresnelsection or zone 512 enables most of the transmission.

For example a 4 MHz lens with a nominal focal depth of 45 mm has a firstor innermost Fresnel zone of about 11 mm in diameter. As shown in FIG.36, the relative power transmission (solid line, left axis) as afunction of radius varies from 100% in the middle to less than 70% inthe outer section, assuming first order polystyrene lens. At the sametime, the outer section or zone produces a larger phase shift (dashedline, right axis) for the propagating ultrasound waves, which isimportant for focusing, while middle section introduces minimal phaseshift to propagating waves. Thus, it is feasible to replace the middleor innermost section with an opening of about 6 mm diameter, which issufficient to provide an imaging window for a movable imagingtransducer. Alternatively, an imaging transducer made of low ultrasoundabsorption piezo-polymer material can be an integral part of a movableand variable focal distances lens, as disclosed above, to enablesimultaneous focusing and imaging at different distances, which isrequired for a controllable, effective and safe ultrasound ablationperformed under ultrasound imaging guidance.

1. An ultrasonic transducer device generating an ultrasound waveform ofwavelength λ, comprising: at least one high-intensity ultrasoundtransducer element made of a piezoelectric ceramic material; an acousticfocusing lens; and a holder assembly, said lens and said module beingmounted to said holder assembly so that said lens is spaced apredetermined distance ${\left( {{2n} + 1} \right)\frac{\lambda}{4}},$nε{0, 1, 2, . . . } from said transducer element, a liquid layer havinga thickness of said predetermined distance being provided between saidlens and said transducer element.
 2. The device defined in claim 1wherein said lens and said transducer element are mounted to said holderassembly so that said lens is movable relative to said transducerelement, thereby enabling a modification of the location of a focallocus relative to said holder assembly.
 3. The device defined in claim 2wherein said transducer element has a planar radiating face and saidlens is configured to have different sections with respective focallengths that differ from each other, said lens being shiftable in aplane oriented substantially parallel to said radiating face toalternately align said different sections of said lens with saidtransducer element, thereby enabling a relocating of said focal locus ina direction normal to the plane of said radiating face.
 4. The devicedefined in claim 3 wherein said lens has a focal length that varies in acontinuous gradient from a maximum focal length to a minimum length. 5.The device defined in claim 4 wherein said lens has a generally tubularor cylindrical form, said focal length varying around a circumference ofsaid lens.
 6. The device defined in claim 3 wherein said lens has aplurality of discrete sections each having a respective focal lengththat differs from the focal lengths of the other sections.
 7. The devicedefined in claim 2 wherein said transducer element has a planarradiating face, said lens being shiftable in a plane orientedsubstantially parallel to said radiating face, thereby enabling arelocating of said focal locus in a plane parallel to said radiatingface.
 8. The device defined in claim 2 wherein said transducer elementis encompassed in between two lenses, each of which has predefined focallength.
 9. The device defined in claim 2 wherein said transducer elementis a cylinder operating in wall thickness mode and wherein said lens isan essentially cylindrical lens having an azimuthally variable focallength, said transducer element being located inside said lens.
 10. Thedevice defined in claim 2 wherein said lens is a disposable andinterchangeable part of the device.
 11. The device defined in claim 1,further comprising at least one imaging transducer element made of apiezoelectric polymeric material, said at least one imaging transducerelement being bonded to one of said at least one high-intensityultrasound transducer element and said lens.
 12. The device defined inclaim 11 wherein said at least one imaging transducer element takes aplanar form and wherein said at least one high-intensity ultrasoundtransducer element takes a planar form having a pair of opposing majorfaces, said at least one imaging transducer element being bonded to oneof said planar major faces.
 13. The device defined in claim 11 whereinsaid at least one imaging transducer element is disposed inside a recessin said at least one high-intensity ultrasound transducer element. 14.The device defined in claim 1, further comprising at least one imagingtransducer movable through said liquid layer between said at least onehigh-intensity ultrasound transducer element and said lens.
 15. Thedevice defined in claim 1, further comprising a solid backing memberdisposed on a side of said transducer element opposite said lens, saidbacking member being spaced by an additional predetermined distance of${n\frac{\lambda}{2}},$ nε{0, 1, 2, . . . }, from said transducerelement, a liquid layer having a thickness of said additionalpredetermined distance being provided between said transducer elementand said backing member.
 16. The device defined in claim 1, furthercomprising at least one metal member operatively mounted to said holderassembly laterally of said lens so as to prevent excitation ofultrasonic vibrations along pathways laterally displaced relative tosaid lens.
 17. The device defined in claim 1 wherein said lens is takenfrom the group consisting of a concave lens, a convex lens, a Fresnellens, a Fresnel multilevel lens, and a Field Conjugate lens.
 18. Thedevice defined in claim 1 wherein said lens is a phase discrete lens,and wherein said transducer element is operable at different operatingfrequencies such that the lens focuses at a predetermined andsubstantially different focal depth at each operating frequency.
 19. Anultrasonic diagnostic and treatment probe comprising: a casing providedat a distal end with a sidewall having a window; a transducer holderdisposed inside said probe; at least one high-intensity or high-powertherapeutic transducer element made of a piezoelectric ceramic andmounted to said holder so as to be juxtaposable to said window; and atleast one imaging transducer element mounted at least indirectly to saidcasing so as to be disposed or disposable in a region about said window.20. The probe defined in claim 19 wherein said holder is provided with aplurality of faces, said holder being rotatably mounted in said casingso that different ones of said faces may be alternately positionedadjacent to and facing said window, said at least one high-intensity orhigh-power therapeutic transducer element being provided on a first oneof said faces, said at least one imaging transducer element beingprovided on a second one of said faces.
 21. The probe defined in claim20 wherein said first one of said faces is oriented at a non-zero anglerelative to said second one of said faces.
 22. The probe defined inclaim 20 wherein said first one of said faces extends parallel to saidsecond one of said faces, said at least one high-intensity or high-powertherapeutic transducer element and said at least one imaging transducerelement being disposed in parallel and facing in opposite directions.23. The probe defined in claim 19 wherein said at least one imagingtransducer element is made of a piezoelectric polymeric material. 24.The probe defined in claim 19 wherein said casing has a firstlongitudinal axis and said holder has a second longitudinal axisextending parallel to said first longitudinal axis, said at least onehigh-intensity or high-power therapeutic transducer element and at leastone imaging transducer element being disposed along a common side ofsaid holder, said holder being longitudinally reciprocatable relative tosaid casing so that said at least one high-intensity or high-powertherapeutic transducer element and said at least one imaging transducerelement are alternatively disposable adjacent said window.
 25. The probedefined in claim 19 wherein said at least one imaging transducer elementis provided on said casing in juxtaposition to said window.
 26. Theprobe defined in claim 19, further comprising an acoustic focusing lensmounted at least indirectly to said casing adjacent to said window. 27.An ultrasonic diagnostic and treatment probe comprising: a casingprovided at a distal end with a sidewall having a window; at least onehigh-intensity or high-power therapeutic transducer element made of apiezoelectric ceramic and disposed inside said casing in juxtapositionto said window; and an acoustic focusing lens mounted at leastindirectly to said casing adjacent to said window.
 28. The probe definedin claim 27 wherein said lens is mounted to said casing so that saidlens is movable relative to said transducer element, thereby enabling achange in the location of a focal locus relative to said casing.
 29. Theprobe defined in claim 28 wherein said lens is shiftable parallel to alongitudinal axis of said casing.
 30. The probe defined in claim 28wherein said lens is rotatable about an axis parallel to a longitudinalaxis of said casing, thereby enabling a relocating of said focal locusalong a radial direction for achieving different focal depths.
 31. Theprobe defined in claim 28 wherein said lens is a probe casing.
 32. Theprobe defined in claim 28 wherein said transducer element has a shapetaken from the group consisting of planar and cylindrical, said lenshaving a form taken from the group consisting of cylindrical andspherical.
 33. A surgical method comprising: providing a high-intensityultrasound device having a transducer element and a focusing lens;placing said transducer device in effective wave-transmitting contactwith a patient; and energizing said transducer element with a frequencypreselected in accordance with the location of a target tissue mass sothat said lens focuses onto said target tissue mass ultrasonic pressurevibrations produced by said transducer element.
 34. The method definedin claim 33 wherein said frequency is a first frequency and said tissuemass is at a first depth in the patient, further comprising energizingsaid transducer element with a second frequency different from saidfirst frequency and preselected in accordance with the location of anadditional target tissue mass at a second depth in the patient so thatsaid lens focuses onto said additional target tissue mass ultrasonicpressure vibrations produced by said transducer element.
 35. A surgicalmethod comprising: providing a high-intensity ultrasound device having aprobe carrying a transducer element and further having a set ofinterchangeable focusing lenses having respective focal lengths andalternately attachable to said probe in an effective focusing positionrelative to said transducer element; determining a depth of a targettissue mass inside a patient; selecting one of said set ofinterchangeable focusing lenses in accordance with the determined depth;attaching the selected lens to said probe in the effective focusingposition; subsequently placing said transducer device in effectivewave-transmitting contact with the patient; and energizing saidtransducer element so that said lens focuses onto said target tissuemass ultrasonic pressure vibrations produced by said transducer element.36. The method defined in claim 35, further comprising: determining adepth of another target tissue mass inside a patient; selecting anotherone of said set of interchangeable focusing lenses in accordance withthe determined depth of said another target tissue mass; attaching saidanother one of said set of interchangeable focusing lenses to said probein a respective effective focusing position; subsequently placing saidtransducer device in effective wave-transmitting contact with thepatient; and energizing said transducer element so that said another oneof said set of interchangeable focusing lenses focuses onto said anothertarget tissue mass ultrasonic pressure vibrations produced by saidtransducer element.
 37. An imaging apparatus comprising an ultrasounddevice having a probe carrying a multiple frequency imaging transducerelement and a focusing lens having a respective focal lengths andtransducer frequency window chosen to improve the sensitivity of deeptissue imaging by having the lens preferentially focus the higherfrequency signals scattered from deeper targets, while lower frequencysignals are preferentially focused from shallower targets.
 38. Anultrasonic transducer device generating an ultrasound waveform ofwavelength λ, comprising: at least one high-intensity ultrasoundtransducer element made of a piezoelectric ceramic material; an acousticfocusing lens; a holder assembly, said lens and said module beingmounted to said holder assembly so that said lens is spaced from saidtransducer element, a liquid layer having a thickness of saidpredetermined distance being provided between said lens and saidtransducer element; and at least one imaging transducer movable throughsaid liquid layer between said at least one high-intensity ultrasoundtransducer element and said lens.